The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of introducing misbranded Su...
FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs.
Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to hold a press confere...
Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book as a way to speed g...
Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported ...
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to ...
FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults...